NCT05550038

Brief Summary

The objective of this study is to evaluate the diagnostic efficiency of general practitioners for the diagnosis of proximal deep vein thrombosis of the lower limbs compared with whole-leg ultrasound with Doppler performed by the vascular physician.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed
Last Updated

September 20, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

September 8, 2022

Last Update Submit

September 19, 2024

Conditions

Deep Vein Thrombosis

Keywords

DVTVein thrombosisThrombophlebitis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of 3 point venous compression

    The diagnostic performance (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value) of 3-point venous compression ultrasound performed by general practitioners for the diagnosis of proximal venous thrombosis of the lower limbs compared to the usual recommended examination (whole leg ultrasound by a vascular physician)

    72 hours

Secondary Outcomes (3)

  • The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner.

    72 hours

  • Duration of the ultrasound performed by the general practitioner in minutes.

    72 hours

  • The interpretability of ultrasound images by general practitioners

    72 hours

Study Arms (1)

compression ultrasound

EXPERIMENTAL

All patients receive a 3-point compression ultrasound followed within 72 hours by a whole-leg ultrasound with Doppler performed by a vascular physician.

Diagnostic Test: Compression ultrasound

Interventions

Compression ultrasoundDIAGNOSTIC_TEST

Patients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis.

Also known as: three-point compression, three-point compression ultrasound, three-point point-of-care ultrasound technique
compression ultrasound

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years
  • Management by a general practitioner trained in 3-point venous ultrasound
  • Suspicion of deep vein thrombosis by the general practitioner with prescription of a whole-leg Doppler ultrasound by a vascular physician. It is noted that the patient can be included from the moment the general practitioner had planned to refer the patient to the vascular physician for a suspicion of DVT, including in the absence of realization of DDimer on a low probability of DVT. It may also be included in case of positive DDimer tests.
  • Signed written consent
  • Patient covered by the French social security system

You may not qualify if:

  • Whole leg ultrasound performed more than 72 hours after the initial examination
  • History of homolateral deep vein thrombosis
  • Patient objecting to the use of his data
  • Refusal of written and signed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Bayeux

Bayeux, Normandy, 14400, France

Location

Avranches

Avranches, 50300, France

Location

Bain de Bretagne

Bain-de-Bretagne, 35470, France

Location

Colombelles

Colombelles, 14460, France

Location

Condé sur vire

Condé-sur-Vire, 50890, France

Location

Honfleur

Honfleur, 14600, France

Location

Ifs

Ifs, 14123, France

Location

Le Chesnay

Le Chesnay, 78150, France

Location

Le pont de montvert

Le Pont-de-Montvert, 48220, France

Location

Lons-le-Saunier

Lons-le-Saunier, 39000, France

Location

Le Molay Littry

Molay, 14330, France

Location

Ouistreham

Ouistreham, 14150, France

Location

Paris rue de Rome

Paris, 75017, France

Location

Percy

Percy, 50410, France

Location

Ploerdut

Ploërdut, 56160, France

Location

Potigny

Potigny, 14420, France

Location

Saix

Saïx, 81710, France

Location

Sannerville

Sannerville, 14940, France

Location

Troarn

Troarn, 14670, France

Location

Related Publications (4)

  • Mumoli N, Vitale J, Giorgi-Pierfranceschi M, Sabatini S, Tulino R, Cei M, Bucherini E, Bova C, Mastroiacovo D, Camaiti A, Palmiero G, Puccetti L, Dentali F; PRACTICUS Study Investigators. General Practitioner-Performed Compression Ultrasonography for Diagnosis of Deep Vein Thrombosis of the Leg: A Multicenter, Prospective Cohort Study. Ann Fam Med. 2017 Nov;15(6):535-539. doi: 10.1370/afm.2109.

    PMID: 29133492BACKGROUND

  • Mumoli N, Vitale J, Cocciolo M, Cei M, Brondi B, Basile V, Sabatini S, Gambaccini L, Carrara I, Camaiti A, Giuntoli S, Dentali F. Accuracy of nurse-performed compression ultrasonography in the diagnosis of proximal symptomatic deep vein thrombosis: a prospective cohort study. J Thromb Haemost. 2014 Apr;12(4):430-5. doi: 10.1111/jth.12522.

    PMID: 24495051BACKGROUND

  • Pomero F, Dentali F, Borretta V, Bonzini M, Melchio R, Douketis JD, Fenoglio LM. Accuracy of emergency physician-performed ultrasonography in the diagnosis of deep-vein thrombosis: a systematic review and meta-analysis. Thromb Haemost. 2013 Jan;109(1):137-45. doi: 10.1160/TH12-07-0473. Epub 2012 Nov 8.

    PMID: 23138420BACKGROUND

  • Lee JH, Lee SH, Yun SJ. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department: A meta-analysis. Medicine (Baltimore). 2019 May;98(22):e15791. doi: 10.1097/MD.0000000000015791.

    PMID: 31145304BACKGROUND

MeSH Terms

Conditions

Venous ThrombosisThrombophlebitis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPhlebitisPeripheral Vascular DiseasesVasculitis

Study Officials

  • Thomas DELOMAS, Dr

    Hospital Saint Lo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All included patients will have a compression ultrasound performed by the general practitioner followed within 72 hours by a whole leg ultrasound with Doppler performed by the vascular physician.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 22, 2022

Study Start

October 3, 2022

Primary Completion

January 23, 2024

Study Completion

January 23, 2024

Last Updated

September 20, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(19)